Bloomberg News reports that the medical device industry is fighting the FDA over the use of the word “recall.” Companies such as Medtronic, Boston Scientific and Guidant have had to deal with the FDA a lot lately over reports of problems with devices such as implantable defibrillators. The FDA calls it a recall when a company has to repair or replace such defective products.
But the industry says “recall” is misleading because faulty device implants don’t have to removed like faulty car parts. So industry wants to replace “recall” with “field corrective actions.”
An industry spokesperson said “We want to communicate clearly with our users and our patients on how to manage our products, and the word ‘recall’ gets in the way.”
Hmmmm. And the words “field corrective actions” help with clear communication?
Posted by schwitz at February 15, 2006 08:04 AM | TrackBack